# K190542: Soliton Acoustic Wave Device

- Pathway: 510(k) (Traditional)
- Applicant: Soliton, Inc.
- Decided: May 24, 2019 after 81 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K950019 (1995). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150212: DeScribe Transparent PFD Patch, On Light Sciences, Inc. (2015) Summary page 4.

## Most influential descendants
- K200331: Rapid Acoustic Pulse Device (2020), 0 descendants of its own

## Indications for use
The Soliton Acoustic Wave Device (AWD) is indicated for use as as an accessory to laser tattoo removal procedures using a 1064 nm Q-Switched laser in Fitzpatrick Skin Type I-III patients.

Source page: https://510kreport.com/device/K190542
Methodology: https://510kreport.com/methodology